Short Term Outcomes After PRoton and PhotoN RadiOtherapy for IDH Mutated Grade 2 and 3 Gliomas
NCT ID: NCT06180434
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
320 participants
OBSERVATIONAL
2024-05-01
2025-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Proton beam therapy has recently become available for the treatment of patients with WHO grade 2 and 3 IDH mutated (IDHmt) glioma in the Netherlands. The dose distributions associated with proton therapy have substantially reduced the volume of the normal brain irradiated with low and intermediate radiotherapy doses. Whether this impacts rates of progressive disease or safety issues and how this compares with a similar population treated with photon therapy is currently unknown.
Objective:
To investigate short term outcomes after proton and photon radiotherapy for grade 2 and 3 IDHmt glioma.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas
NCT05190172
Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology
NCT04648462
Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma
NCT03180502
Accelerated Hypofractionated Intensity - Modulated Radiotherapy After Hyperbaric Oxygenation for Recurrent High Grade Glioma.
NCT03411408
Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
NCT00003375
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Retrospective data will be collected from the electronic records of each participating institute. For the primary outcome, data will be collected on interventions (radiotherapy, surgery, chemotherapy, medication) for either tumor progression or toxicity after radiotherapy. This will be used to calculate next intervention free survival as primary outcome.
For the secondary outcomes, data on survival, disease progression, pseudoprogression, and toxicity will be used to calculate overall survival, progression free survival, and pseudoprogression free survival, as well as toxicity incidence.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Proton group
Patients with grade 2 and 3 IDHmt glioma treated with proton therapy in Holland PTC, Maastro Clinic and UMC Groningen.
proton therapy
Radiotherapy delivered with protons
Photon group
Patients with grade 2 and 3 IDHmt glioma treated with photon therapy in Erasmus MC, Haaglanden MC, LUMC, Amsterdam UMC locatie VUmc Site, Verbeeten Institute, Maastro Clinic, UMC Groningen, and Leuven University Hospital.
photon therapy
Radiotherapy delivered with photons
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
proton therapy
Radiotherapy delivered with protons
photon therapy
Radiotherapy delivered with photons
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Treatment with radiotherapy delivered between 1 of January 2018 and completed before or on the 30th of June 2022
* Treatment with chemotherapy delivered after radiotherapy (PCV or Temozolomide)
* Age ≥ 18 years
Exclusion Criteria
* Contra-indication for MRI imaging
* Chemotherapy delivered before radiotherapy
* Dose and fractionation other that standard dose (50.4 Gy in 28 fractions for Grade 2 and 59.5 Gy in 33 fractions for Grade 3)
* Combination photon and proton therapy
* Patient has previously opted-out of the use of their data for research
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical Center Haaglanden
OTHER
Leiden University Medical Center
OTHER
HollandPTC
INDUSTRY
Institute Verbeeten
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
University Medical Center Groningen
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Maastro Clinic, The Netherlands
OTHER
Erasmus Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alejandra Mendez Romero
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alejandra Mendez Romero, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Assitant Professor, Radiation Oncologist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Erasmus MC
Rotterdam, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Steven Nagtegaal, MD PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MEC-2023-0727
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.